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To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses

NCT00648973 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1021

Last updated 2011-08-22

No results posted yet for this study

Summary

The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.

Conditions

  • Nasal Congestion

Interventions

DRUG

Diphenhydramine 50 mg

Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet

DRUG

Diphenhydramine 25 mg

Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet

DRUG

Pseudoephedrine 120 mg

Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Melissa Israel, BS · McNeil Consumer Healthcare Division of Mc-Neil-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648973 on ClinicalTrials.gov